Document Control Specialist

Organization
Pacific Biosciences
Job Location
1380 Willow Road
Menlo Park, CA 94025
Job Description

Responsible for structuring and populating MFG applications (SAP, AGILE) with new product information such as part numbers, bill of materials, and other product related information. The new product information will come from various internal customers, including; Operations, Engineering, and Finance. The information will be checked for completeness and integrity, as processed through Document Control’s Change Control process.  The candidate should possess the technical aptitude and knowledge to work within these structures, functions, and applications in order to adequately and efficiently support a high volume Medical Research & Development and Manufacturing environment. 

 Responsibilities:         
•    Will assist in the entry and maintenance of all product documentation, as well as, ensure timely, thorough, and accurate release of Change Orders, and Manufacturing Change Orders processed through Agile and SAP.
•    Ensure processes for maintaining controlled quality system and product documentation in electronic format (e.g. drawings, procedures, Bills of materials, spec, technical literature and etc.) are well defined to meet company business management system requirements.
•    Ensure accuracy and integrity of data maintained in Document Control databases.
•    Lead and manage Change Control Board (CCB) meetings.
•    Will support Document Control customers in achieving targeted product launch schedules.
•    Will be held responsible for integrity and accuracy of data entered into MRP/ERP databases as dictated by electronic Change Orders.
•    Ensure processes for maintaining controlled quality system and product documentation in electronic/hard copy format (e.g. drawings, procedures, quality system records, bills of materials, specs, technical literature and etc.) are well defined to meet company business management system requirements.
•    Will assist in performing Agile PLM and other departmental training sessions, upon request.
•    Will develop and review procedures, and other quality system documentation to ensure adherence to Good Manufacturing Practice (GMP), ISO 13485 requirement, or other related procedures.
•    Will assist with creating and maintaining relevant Document Control metrics and reports.
•    Provide administrative/project support related to documentation system requirements.

Requirements

•    Experienced in ISO 9001 and ISO 13485 requirements and 21 CFR820 Requirements, and FDA regulations/guidelines.
•    Experience in the medical device or diagnostics industry.
•    A thorough understanding in use of PLM and ERP applications (i.e., Agile and SAP).
•    Direct hands on experience with processing Change Orders using Agile PLM.
•    A thorough understanding of MFG Process flow, bill of material structures (BOMs), and part number interchangeability.
•    Strong background in revising, reviewing, and processing discrete and process BOMs and drawings (i.e., schematics, PCB, Software, etc.).
•    Strong skills in creating and maintaining required Document Control metrics.
•    Demonstrated ability to follow instructions/schedules/timelines and handle multiple priorities in a dynamic environment.
•    Strong interpersonal skills and ability to work with others in a positive and collaborative manner.
•    Strong working knowledge of Adobe Acrobat, and MS Office- especially Word, Excel, and Visio.
•    Ability to work in a high volume fast paced environment with minimal instruction on routine work, and general instructions on new assignments.
•    Ability to implement departmental process improvement recommendations that will support the strategic business goals of the company.
•    Must be a self-starter with a strong focus on quality, and exercises good judgment within broadly defined practices and policies in selecting methods, techniques and criteria for obtaining results.
•    Undergraduate degree preferred, MBA a plus.

About Our Organization

Pacific Biosciences’ mission is to transform the way humankind acquires, processes and interprets data from living systems through the design, development and commercialization of innovative tools for biological research. The company has developed a novel approach to studying the synthesis and regulation of DNA, RNA and protein. Combining recent advances in nanofabrication, biochemistry, molecular biology, surface chemistry and optics, Pacific Biosciences has created a powerful technology platform called single molecule, real-time, or SMRT™, technology. SMRT technology enables real-time analysis of biomolecules with single molecule resolution, which has the potential to transform the understanding of biological systems by providing a window into these systems that has not previously been open for scientific study. 

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